Daily GS Mains Notes or Mains Content Enrichment for Civil Services Exam (Arora IAS)
ICMR looks at vaccine launch by Aug. 15
WHY IN NEWS
- The vaccine “Covaxin” developed by Bharat Biotech India Ltd (BBIL), Hyderabad, has got approvals from the Drug Controller General of India for phase-1 and phase-2 trials.
- The potential vaccine in question is a SARS-CoV-2 strain sourced from the ICMR-National Institute of Virology. The trials are done on groups of people and are meant to test if the vaccine is safe on humans and produces protective antibodies
Category: INTERNATIONAL RELATIONS
2.‘India not to import power equipment from China’
Why in news
- The Union Power Minister stated that India will not import power equipment from China, cause this sector was vulnerable to cyber attacks Any import of equipment from prior reference countries will require prior permission of the government, the Minister said, that such permission won’t be available for either China or Pakistan.
- China has over the last few years been a major source of power equipment for India, with a share of roughly a third of the total imported machines in terms of value.
- Imports of these capital-intensive machines have been rising at a fast rate
- China constituted close to 30 percent of the total imports in the electrical equipment segment in FY19. The Minister highlighted the need for self-reliance in the sector.
India’s progress in the power sector:
- A lot has been achieved in the power sector, including capacity addition of 15,000 MW a year since 2014, and connecting the entire nation through one grid.
3.Centre accepts marines case ruling:
Why in news
- The Centre informed the Supreme Court that it has decided to accept and abide by the international tribunal’s ruling that the Italian marines accused of killing two fishermen off the coast of Kerala in 2012 enjoy immunity and are outside the jurisdiction of Indian courts.
- The award is a substantial victory for India inasmuch as:
- Concurrent jurisdiction was recognized, but immunity clause was applied to take the trial out of India.
- The compensation claim was allowed.
- Counterclaim for compensation by Italy was denied.
- India is bound by the award of the arbitral tribunal formed under the United Nations Convention on the Law of the Sea (UNCLOS). The award is final and without appeal, as India is a party to the U.N. Convention.
4.‘Japan against unilateral action that changes status quo along LAC’
Why in news
- Japan opposes unilateral action that changes the status quo along the Line of Actual Control (LAC) between India and China”, said Japanese Ambassador Satoshi Suzuki in a discussion with Foreign Secretary Harsh Vardhan Shringla on the India-China standoff in eastern Ladakh.
- The discussion follows a joint exercise held by the two countries in the Indian Ocean.
- The exercise in the Indian Ocean is significant as China is trying to increase its military presence in this region.
- There is growing talk of the possibility of the emergence of a joint front of India, Japan, the US and Australia (Quad) to counter the threat of the Chinese Navy in the region.
- There is also growing tension between Japan and China over the Senkaku islands.
- Japan had backed India during the Doklam standoff with China and has also expressed condolences on the death of 20 Indian soldiers in Galwan Valley during a clash with Chinese soldiers.
5.Governance and Ethics
Why In NEWS:
- COVEX and PANTAJLI CASE (BABA RAMDEV). The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019
Features of New Rules
- The new rules aim to provide for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
- the time for approving applications, has been reduced to 30 days for drugs manufactured in India and 90 days for those developed outside the country. In case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.
- Ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
- New rules has removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well regulated
Phases of Clinical Trials
- Phase I or clinical pharmacology trials or “first in man” study: This is the first time where the new drug is administered to a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor.
- Phase II or exploratory trials: During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
- Phase III or confirmatory trials: Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate.
- Phase IV trials or post-marketing phase: Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
Regulatory Mechanism in India
- Clinical trials in India are governed by the acts: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian
Key Issues with Clinical Trials
- 2013 Amendments to the Drugs and Cosmetics Act led to better protection of vulnerable groups but presence of ambiguous language is a concern.
- over-representation of low income groups among trial subjects. Sometimes Clinical Research Organisations (CROs) recruit them selectively and exploit their ignorance. Their only reward from the trial is financial.
- Many times consent of the participants in the clinical trials is not taken. In most cases ethics committee is not constituted and people on such committees are not well trained.
- There is lack of independence for ethics committee working. There is need to register with Clinical Trials Registry of India for all clinical trials conducted in India. But registration is mostly done for positive trial So there is lack of transparency. There are no well developed international standards dealing with clinical trials.
- India is a signatory of the Declaration of Helsinki but that is voluntary in nature and lack regulatory mechanisms. Three tier approval mechanisms has also led to delays in approval. Collusion between drug companies and doctors. Compensation for participating in research as well as research related injury is a major bone of contention these days. Moreover, regulatory failure and unethical clinical trials are also major issues.
- The ethical issues in clinical research primarily involves: Protection of Rights, Safety of subjects
- Well being of the research participants, Informed consent and Voluntary Agreement of the participant, Maintain privacy of the participant, Accountability and transparency while conducting trials.
- Research and trial details should be in public domain.